Your Device Made It To Market, Now What? Post-Market Surveillance
How reliable is your device in the real world? Medical device post-market surveillance answers this question by telling us if pre-market assessments gave a true reading on safety and efficacy. Depending on the device (and region), regulatory agencies require manufacturers to establish and maintain Post-Market Surveillance (PMS) programs.
QA Consulting consultants are experts in regulatory compliance and quality assurance — including post-market surveillance — and we’re here to help medical device manufacturers get and keep their devices on the market. Continue reading to learn the basics of PMS and contact us to see how our knowledge can ease your post-market journey.
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What is Post-Market Surveillance?
PMS is the process of monitoring medical devices for safety and efficacy once they’ve reached the market.
Through PMS, you’ll gain insights into:
- Adverse events (as part of pharmacovigilance).
- Performance and clinical outcomes compared with current standards of care.
- Risks and benefits of the device for the intended population.
PMS is a critical part of a device’s technical documentation. It needs to remain accurate and up-to-date for regulatory reporting and audits.
Is Post-Market Surveillance required for your medical device? If so, for how long?
In the United States, the FDA requires medical device post-market surveillance for certain classes of medical devices.
The FDA expects medical device PMS for Class II and III devices that are:
- Used in pediatrics.
- Implanted for longer than one year.
- Likely to pose serious risk or adverse health consequences if they fail.
- Intended for life-sustaining applications outside of a medical facility.
Post-market surveillance timelines vary depending on the type of device. Some timelines can go on for years. For instance, the FDA requires post-market surveillance beyond 36 months for certain pediatric devices.
This process looks a bit different in the European Union, where post-market surveillance is required for all manufacturers of medical devices, and is not limited to higher-risk devices. The duration and frequency differs. The EU MDR requires updated PMS reports every six months once the product is authorized (even if it is not marketed), requires PSUR submissions annually or biennially for two years once a product is marketed, and thereafter every three years.
QA Consulting provides you with consultants that best match your specific medical device and post-market surveillance requirements. Our team has consultants trained in both US and EU regulations.
How to Plan Medical Device PMS
According to the World Health Organization, planning a manufacturer post-market surveillance program involves seven components:
- Scope: Define the scope and type of surveillance planned.
- Objectives: Define the objective(s) or goal(s) of the surveillance plan.
- Responsibilities: Outline the manufacturer’s responsibilities for all stages of the surveillance process.
- Data Collection Methods: Describe the methods for collecting data.
- Data Analysis Methods: Describe the methods for data analysis.
- System Creation: Create a system for inputting collected and analyzed data and assessing risk based on those data.
- Risk Assessment & Reporting: Determine and implement action items that result from the analyzed data and subsequent risk assessment. Depending on the risk assessment, the timing and manner for reporting these risks may vary dramatically. For instance, a severe risk to public health must be reported immediately (i.e., within 48 hours). Less serious risks will have a longer time to report.
Do you have a reliable risk management plan? Learn from the experts on how you can mitigate risk as you develop and manage your medical devices.
How Do You Conduct Medical Device PMS?
After you’ve got a plan of action—ideally built in collaboration with an expert—there are four core activities involved in the execution of a manufacturer PMS program.
- Data collection (required)
- Data evaluation (required)
- Root-cause analyses (as needed)
- Corrective actions (as needed)
Collect Feedback and Other Forms of Surveillance Data
The bulk of data will involve feedback from clients, patients, and/or healthcare providers. However, other valuable information can be obtained from scientific literature, generated training guides, media (traditional and social), incident reports, explant cases, and more.
Evaluate Feedback and Report to National Reporting Authority
Once collected, feedback must be evaluated to perform risk assessment. If a reportable risk is identified, it will need to be reported to the appropriate national reporting authority (NRA). The timing and content of these reports will vary based on the severity of the risk identified.
Conduct Root-Cause Analysis
If necessary, you should conduct a root-cause analysis to determine whether a causative relationship between the observed risk and the use of the medical device can be established.
Make Corrections and/or Implement Corrective Actions
Following the evaluation of feedback and root-cause analysis, a manufacturer must determine whether corrective action is necessary and if so, what type of correction is needed. A correction may include the repair, modification, adjustment, relabeling, inspection or even destruction of the device. It might also include further surveillance, retraining, clarifications to proper use, or retesting of the device.
A field safety corrective action (FSCA) is issued if the risk is deemed unacceptable. This can occur during a malfunction or a severe deterioration of safety or effectiveness. A field safety notice (FSN) is used to clarify and train providers on the proper use of the device as well as address less severe risks or identified use errors.
Medical Device Post-Market Surveillance Expertise at QA Consulting
If the process and tasks discussed sound overwhelming, you’re not alone. QA Consulting is here to help you plan, navigate, and implement all aspects of medical device PMS. By leveraging the experience of an expert in post-market surveillance services, the process becomes thorough, painless, and risk-reduced.
We work as an extension of your team. Our experts create customized solutions that help you deploy regulatory and quality affairs strategies that will achieve your business goals.